Observatory of the Lille Paediatric Allergy Unit (PAUL)

Paediatric Observatory of Oral Food Tolerance Induction in the Allergy Department of the Saint-Vincent de Paul Hospital in Lille

The goal of this study is to set up a paediatric observatory within the allergology department of The saint Vincent Hospital, Lille. The study aims to:

• Collect exhaustive prospective data from patients eligible for oral immunotherapy.

This prospective observatory will enable statistical analyses to be carried out on common food allergens such as hazelnut, cashew nut, pistachio and others.

Study Overview

• Status: Recruiting
• Conditions: Food Allergy; Child Allergy; IgE-Mediated Allergic Process
• Intervention / Treatment: Other: Oral immunotherapy

Detailed Description

During the consultation, the allergist will inform the legal representative and the child about the terms of the study, and will provide them with an information note specifying the objectives of the study and its terms, the involvement of the child and his or her rights.

Depending on the allergen involved, the oral immunotherapy session will be assigned to one of three study groups: 1) allergen to hazelnut, walnut, pistachio, cashew or peanut,2) allergen to cow's milk, wheat or egg, 3) allergen to unusual foods: sesame, celery, fenugreek, peas, lentils, etc.

For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

Oral immunotherapy will then be started in accordance with standard practice. During this first visit, the investigator will give the patient a diary in which to record information about any IgE-mediated side-effects of the oral immunotherapy. Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol. Visits will be made every 6 months, with a window of two months around each date.During these monitoring visits, tthe collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be continue.

During each visit, a new food challenge test may be performed at the investigator's discretion to assess a new reactogenic threshold. Following this test, the following data will be collected:

• the cumulative dose ingested (mg food and mg food protein)
• the grade of the reaction (from 0 to 5 according to the Astier et Coll classification)
• achievement of desensitisation

A patient begins oral immunotherapy following food challenge test in a day hospital. Thus, a patient consulting at different times for several allergies and eligible for several oral immunotherapies will be able to take part in the study for several allergens. The follow-up of the different oral immunotherapies started (maximum 2 simultaneously, but could go up to 5, 6... over time) will be distinct. The patient may therefore participate several times in the study: in different groups, or in the same group, for different allergens. All the above data are collected separately for each new oral immunotherapy (except for socio-demographic data and information on previous oral immunotherapies, which are collected only at the time of inclusion).

In very rare cases, a patient may undergo several oral immunotherapies for the same allergen, but only the first oral immunotherapy (from the time the observatory was set up) will be taken into account in this study. If oral immunotherapy for the same allergen has already been carried out before the observatory was set up, the second oral immunotherapy for this allergen will not be included in the study, as its results will be biased.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Domitille Tristram; Phone Number: + 33 3 20 22 57 37; Email: tristram.domitille@ghicl.net

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • Groupement de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul
    • Contact: Tomas MORALY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients consulting at the allergology service of the Saint Vincent Hospital, Lille, France will be informed and included, unless they object.

Description

Inclusion criteria:

• patient under 15 years and 9 months,
• positive diagnosis of food allergy (positive food challenge test or "highly probable allergy", defined by a convincing history, a positive prick test and IgE > 0.35 kUA/L),
• eligible for oral food challenge
• accepting the following allergens : hazelnut, walnut, pistachio, cashew, peanut, cow's milk, wheat, egg, sesame, celery, fenugreek, pea, lentils or others

Exclusion criteria:

• Opposition
• Already received oral challenge for the same allergen.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Allergy to hazelnut, walnut, pistachio, cashew or peanut	Other: Oral immunotherapy; Clinical Follow up
Group 2; Allergy to cow's milk, wheat or egg	Other: Oral immunotherapy; Clinical Follow up
Group 3; Allergy to unusual foods: sesame, celery, fenugreek, peas, lentils or others	Other: Oral immunotherapy; Clinical Follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done	at inclusion
Sex	For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done	at inclusion
Oral immunotherapies followed before inclusion	For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done	at inclusion
Determination of comorbidities	For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done	at inclusion
Determination of allergen under consideration	For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done	at inclusion
Specific IgE	For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done	at inclusion
Recombinants	For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done	5 years
Cumulative ingested dose	This dose will be determined by mg/food and m/ food protein	5 years
Allergic reaction according to the Astier and Coll classification	Astier score for anaphylaxis according to symptoms: 0- Absent 1- Abdominal pain spontaneous resolution, Urticaria < 10 papules, Eczema, Rhinoconjunctivitis 2-1 Organ affected, Abdominal pain requiring treatment, Angioedema with laryngeal involvement, Moderate asthma: cough and PEF > 20%. 3- 2 Affected organs 4- 3 organs affected or Asthma attack requiring treatment or Laryngeal edema or Arterial hypotension 5- Cardiorespiratory impairment requiring ICU admission	5 years
Type of oral challenge	Type of ingested food during the oral immunotherapy: fresh food / industrial products	5 years
Reception of emergency kit	If the reception of an emergency kit was needed will be determined by yes/no	5 years
Second oral food challenge	If a second oral challenge was needed will be determined by yes/no	5 years
Tolerance according to reactogenic thresholds for allergens	Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.	5 years
Amount of reactions IgE mediated	Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.	5 years
Amount of reactions non IgE mediated	Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.	5 years

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Tomas MORALY, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Food allergy; Observatory; Food challenge test; IgE-Mediated
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: RNIPH-2021-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No